Skip to content

Impact of a High-Protein Diet on Clinical Outcomes in Mechanically Ventilated Patients With Severe Pneumonia

Impact of a High-Protein Diet on Clinical Outcomes in Mechanically Ventilated Patients With Severe Pneumonia

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07634328
Enrollment
60
Registered
2026-06-08
Start date
2025-10-09
Completion date
2026-10-01
Last updated
2026-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mechanically Ventilated Patients, Severe Pneumonia

Keywords

high-protein diet, quadriceps ultrasound, severe pneumonia

Brief summary

prospective, comparative, observational study will be conducted at the Critical Care Department, Fayoum University Hospital, to evaluate the impact of a high-protein diet versus a standard-protein diet in mechanically ventilated patients with severe pneumonia.

Detailed description

prospective, comparative, observational study will be conducted at the Critical Care Department, Fayoum University Hospital, aims to evaluate the effect of a high-protein diet on clinical outcomes in mechanically ventilated patients with severe pneumonia, focusing on muscle preservation and weaning ability. The specific objectives are: 1. To assess the impact of high-protein intake on skeletal muscle mass using quadriceps ultrasound. 2. To evaluate diaphragmatic function and thickness in relation to protein intake using ultrasound. 3. To determine the effect of high-protein nutrition on weaning success, duration of mechanical ventilation, length of hospital stay and mortality.

Interventions

None listed

Sponsors

Fayoum University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Age ≥ 18 years. * Mechanically ventilated patients with severe pneumonia. * Expected ICU stay ≥ 72 hours.

Exclusion criteria

* Patients who died before 72 hours of ICU admission. * Chronic liver failure or decompensated cirrhosis. * End-stage renal disease (CKD stage 5 or dialysis dependent). * Neuromuscular diseases or pre-existing severe muscle wasting. * Pregnancy. * Patients with pre-existing malnutrition (e.g., BMI \<18.5 kg/m² ). * Contraindications to enteral feeding, such as: 1. Mechanical bowel obstruction. 2. Severe gastrointestinal bleeding. 3. High-output fistulas involving the gastrointestinal tract. 4. Recent gastrointestinal surgery preventing enteral access.

Design outcomes

Primary

MeasureTime frameDescription
Duration of mechanical ventilationFrom enrollment to the end of treatment at 1 to 2 weeksThe total time in days during which the patient receives invasive mechanical ventilatory support through an endotracheal tube or tracheostomy, calculated from the initiation of mechanical ventilation until successful liberation from the ventilator or death.
Weaning Success1 to 2 weeksSuccessful discontinuation of mechanical ventilatory support with maintenance of spontaneous breathing after extubation, without the need for re-intubation, reinstitution of invasive mechanical ventilation, or death within 48 hours.

Secondary

MeasureTime frameDescription
Preservation of Quadriceps Muscle Mass Assessed by Ultrasound2 weeksPreservation of quadriceps muscle mass was assessed using bedside ultrasonography by measuring the quadriceps muscle thickness at predefined anatomical landmarks. Muscle preservation was defined as the percentage change in muscle thickness from baseline to the follow-up assessment, with a smaller reduction indicating better preservation of muscle mass.
Diaphragm Muscle Thickness Assessed by Ultrasound2 weeksDiaphragm muscle thickness was assessed using bedside ultrasonography in the zone of apposition of the diaphragm. The thickness of the diaphragm measured by ultrasound at the zone of apposition, expressed in millimeters (mm). Measurements were obtained at end-expiration, and the percentage change from baseline was used to assess diaphragm muscle preservation or atrophy. Diaphragm Thickening Fraction (DTF) (%)=(DT at end-inspiration - DT at end-expiration) ÷ DT at end-expiration × 100. TF ≥ 20% is considered normal; \< 20% suggests diaphragmatic dysfunction.
Incidence of ICU-Acquired Weakness1 to 4 weeksThe percentage of patients who develop ICU-acquired weakness during ICU admission. ICU-AW was diagnosed when the MRC sum score was \<48/60 during ICU admission.
ICU Length of Stay2 to 4 weeksThe number of days spent in the ICU, calculated from ICU admission to ICU discharge, transfer to another ward, or death during ICU stay.
Mortality2 to 4 weeksThe proportion of patients who die during their ICU stay, calculated from ICU admission until ICU discharge.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 9, 2026